A Seminar On Quality Audit Prepared by :- Heena D. Makwana M.Pharm (Q.A Sem-1) A.P.M.C College of pharmacy
Quality Audit Quality Audit Quality audit is defined as a systematic and independent examination to determine whether activities and related results comply with planned arrangements and whether these arrangements are implemented effectively and are suitable to achieve objectives
Objectives Of Quality Audit Pharmaceutical manufacturers commonly use audits as an effective mechanism to verify compliance with GMP regulation (GMP).GMP audits with two important goals Audis are intended to verify that manufacturing and Control systems are operating under a state of control. Audits permit timely correction of potential problems. Audits can be used to establish a high degree of confidence to remain under an adequate level of control by managements
Self InspectionPrinciple:- To evaluate the manufacturer’s Compliance with GMP in all aspects of production and Quality control. Performed routinely as well as on special occasions, e.g. in the case of product recalls or repeated rejections
Items of Self inspection Personnel Premises including personnel facilities Maintenance of buildings and equipment Storage of starting materials and finished products Equipment Production and in-process controls Quality control To be Continued………
Conti.… Documentation Sanitation and hygiene Validation and revalidation programmes Calibration of instruments or measurement systems Recall procedures Complaints management Labels control Results of previous self-inspections and any corrective steps Taken
Types Of Quality AuditThe quality audit system mainly classifiedin three different categories: 1. Internal Audits 2. External Audits 3. Regulatory Audits
Internal AuditPurpose of Internal audit:- To Ensure that adequate Quality systems are maintained To asses compliance with the C-GMP’s and firms standard operating procedure To achieve consistency between manufacturing and testing facilities To identify problems internally and Correct problems prior to a FDA inspection
Designing of the Internal Audit System In a pharmaceutical facility for internal auditing, you require to check mainly two things namely − Activities carried out by different departments − Documents maintained by these departments
Implementing the Internal Audit Program Constitute a small team of experts Provide Initial training Fix Audit schedule (Carried out at least once in Six months) Report the Audit finding and report given to top management and Shows corrective actions Repeat the audit as per preplanned Schedule
External Audit External AuditPurpose of External Audit:- Confidence in the partnership arrangement Ensuring that requirements are understood Reducing the risk of failure Carried out by company on its vendors No legal requirement to conduct the audit External audit have experience of GMP as well as regularly audited by their certification body
Regulatory AuditPurpose of Regulatory audit:- Networking and confidence-building between national inspection authorities Development of quality systems Work towards global harmonisation of GMP Conti….
Conti…. Carried out by regulatory bodies such as MCA(U.K),USFDA(USA) for manufacturing and supply of pharmaceutical product Audits may be unannounced After regulatory audit , a formal report will be delivered For MCA:- verbal feedback report is given at the exit meeting For USFDA:- Provides “Form 483”is given at the exit meeting
Role of GMP Audits in Q.A And Q.C programmesWhat is to be audited:- Auditors review SOPs Employees pracices and behaviour Compare master specifications against compendial and regulatory requirements Verify the test data and validation testing Validation test reports are compared against raw data
Benefitswhich are derived from Audits are given below: Assuring GMP compliance Detecting Potential Problems Effecting Programme improvement Increasing management awareness
Increasing Management Awareness For any given audits there are two outcomes,either problems are found or not If the problems are found , management takes an approprioate step to eliminate the problem An audit is not finding any objectionable conditions Either there were no problems to be found Auditor failed to detect objectionble condition that were actuaslly present
Elements of a Systemic Audit Program Key Elements Expectations and Philosophies Audit Formats and Approaches Checklist format GMP regulation approach System analysis methods Checklist written criteria and Standard Operating Procedures Planned periodic frequency for audit Specially trained personnel Finding Written Audit reports
Audit Format And Approaches Manual GMP audit methods can be divided in to categories Checklist format GMP regulation approach Systems analysis method
Checklist Format Use checklist as GMP audit guides and reporting finding. Series of questions or instructions are grouped in to logical order. Blocks may be used to record answer and space may be provided to make comments.
GMP Regulation Format The basic elements are derived from the following subpart of regulations Subpart B: Organization and personnel Subpart C: Building and facilities Subpart D: Equipments Subpart E: Production and Processing Controls Subpart F: Production and Packaging control Subpart H: Holding and Distribution Subpart I: Lab controls Subpart J: Records and Reports Subpart K: Returned and Salvaged drug
Written Criteria And SOPFormal written SOPs should fully describe the details for carrying out the various audit functions.Effective use of written criteria to ensure that conditions and practices remain under a suitable state of controlSOPs should establish The responsibility for audit data review Personnel responsible for recommendations Decisions concerning corrective actions.
Planned Periodic Frequency Each firm must establish the optimum time interval between audits based on several important factors like Intended purpose Objectives, scope and depth Prior history of audit finding.Two types of visit Can be done depending on the type of audit:- AnnouncedVisit Unannounced Audit
Conti…. Announced Visits: Advanced notice is given before the audit. It is not persuasive for two reasons The employee covers up the problem. The person makes major adjustment in their behavior Benefits :- Audit efficiency is improved from advance notification Necessary records may be organized and retrieved in the preparation for the audit. Key personnel become available Conti….
Conti….Unannounced Audits To view conditions and practices that is normal or customary (representative) as possible. For observing employees behavior as well as observation of equipments and facilities. Benefits :- Allows observation of normal condition and practices
Specially Trained Personnel The following personnel factors deserve systemic attention Defining auditor Qualification Documentation training skills and Experience. Selecting audit teams Maintaining auditor awareness levels
Defining Auditor Qualification Selected based On their knowledge Experience in manufacturing and QC principles as well as years of first hand experience dealing with GMP matters.Essential auditor skill is aware of Firm’s SOPs and Knowledge Integrated by various departments.
Documentation Training Skills And ExperienceTwo formats Scientific Principles Training under chemistry, engineering, statistical and pharmaceutics GMP GMP training may include the cumulative knowledge from years of experience This knowledge comes from Daily activities Formal training sessions
Selecting Audit teams Limitations of Personnel audit Experience and knowledge, which is individual. Emphasize on familiar issues as well as particular area Team is required for cover many different systems and large amount of data. Composition of team will vary depending upon the nature and scope of the audit Conti….
Conti….Leader is usually a senior auditor who has extensive knowledge of the firm’s operations and exhibit strong leadership qualities.Team size depends upon Firm size Total no of products manufacturing and control system Breath and depth of the audit. The Audit objective
Reporting Audit Finding Audit reports should contain complete details of the program detected. Corrective action is taken to eliminate problems and to measure the overall adequacy of the audit program uses reports.There are two important reporting phases:- 1) Preliminary reports during the audit 2) Final report to the management
References PharmaceuticalDosage forms:Parenteral medication,Revised and Expanded.Edited by Kenneth E.Avis,Herbert A.libermann and Leon Lachmann,Volume –3, Second edition , Page no:-363-420 QualityManual, D. H. Shah, First edition, Page no:- 184-216